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Review date of multiple sclerosis drug pushed back

Category: Autoimmune Diseases

Reuters has reported that a new drug, BG-12, which will be used to treat multiple sclerosis (MS), will have its review from the U.S. Food and Drug Administration (FDA), pushed back by three months.

BG-12, or dimethyl fumarate, which was developed by biotechnology company, Biogen Idec Inc. will be the second oral MS drug available. According to Science News Magazine, clinical trials have shown that BG-12 significantly increases the time between relapses of the disease's symptoms, which include impaired muscle control, balance, vision and speech.

The positive results of the drug, along with the lack of safety concerns, have prompted Biogen Idec Inc's stock to rise 50 percent over the last year, Reuters notes. The recent setbacks caused a 2 percent decrease in the stock's value, bringing it to $150.72 as of the morning trading period on Oct. 18.

According to the news source, there will be no more studies required by the FDA, but more time is needed to review the application. Analysts claim that this is not uncommon, especially with the large amount of patients involved in the registrational studies. Both DEFINE and CONFIRM test, looked at BG-12's effectiveness for warding off the effects of MS compared to a placebo.

"The registrational studies for BG-12 - DEFINE and CONFIRM - enrolled about 1,200 and 1,400 patients, respectively" said Barclays Capital analyst Anothony Butler to Reuters. "Given the size and complexity of the filings, we are not surprised that the FDA would require additional time to review the application."

Reuters also reported that analysts predict BG-12's sales will hit $390 million in 2013 and rise to $980 million the following year. The drug is presently undergoing regulatory review in the European Union, Australia and Canada.

Multiple sclerosis symptoms
According to the National Institutes of Health (NIH), MS is an autoimmune disease that impacts the brain and central nervous system by damaging the the protective layer around nerve cells known as the myelin sheath. The sheath is involved with the delivery process of the nerve signals, and when it's damaged, the signals are slowed or stopped.

The NIH reports that inflammation is the culprit when it comes to the nerve damage, which is the result of the immune system attacking the central nervous system, and it can occur not only in the spinal cord and brain, but also in the optic nerve.

Diagnosis
MS is usually diagnosed by ruling out certain ailments, such as other infectious or inflammatory diseases and viral infections that have similar symptoms, which are detected with spinal taps and blood testing. MRIs can also reveal lesions, which are signifiers of a depleted myelin sheath on the brain or spinal cord.